Nevirapine resistance developed in women and infants in the HIVNET 006 and 012 cohorts as a consequence of use of an agent with a long t½ as monotherapy in individuals with high viral loads.

Objective 1 To demonstrate that Nevirapine resistance does not develop in HIV infected patients when used as part of triple antiretroviral combination therapy between the initiation of treatment and suppression of HIV RNA to <1000 copies/ml.

Objective 2 To demonstrate that resistance to nevirapine does not develop when patients with suppressed HIV RNA discontinue combination antiretroviral therapy which contains nevirapine.

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:

To demonstrate that Nevirapine resistance does not develop in HIV infected patients when used as part of triple antiretroviral combination therapy between the initiation of treatment and suppression of HIV RNA to <1000 copies/ml. [ Time Frame: during viral suppression ] [ Designated as safety issue: No ]

Decision to discontinue ARV therapy at the completion of pregnancy or for a drug holiday

Not resistant to nevirapine.

Note that since most patients meeting the criteria for Objective 1 are expected to achieve HIV RNA < 50 copies/mL, the patient populations for Objectives 1 and 2 will be almost the same.

Exclusion Criteria:

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00193947